Compositions and methods for tissue regeneration

ABSTRACT

Methods and compositions using an orthosilicate for tissue regeneration, such as to treat a disease or condition, are described, including on the skin. Also described are methods for making such compositions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional Application of U.S. application Ser.No. 14/103,116, filed Dec. 11, 2013, which claims priority to U.S.provisional patent application No. 61/736,257, filed on Dec. 12, 2012,and 61/786,380, filed on Mar. 15, 2013. The contents of the priorapplications are incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

Described herein are methods and compositions using an orthosilicate forproviding tissue regeneration, such as to treat a disease or condition,including on the skin. Also described are methods for making suchcompositions.

BACKGROUND

Damage to skin, underlying muscle and other surrounding tissue can occuras the result of a number of diseases and conditions. Such damage can belong-lasting and result in physical damage to these tissues.

For example, acne develops because pores in the skin are clogged withoil from hair follicles, resulting in a build up of matter such asbacteria and cells. If left untreated, long-lasting acne can result inscarring and disfigurement of a person's skin, such as on the person'sface.

Additionally, different types of skin cancer, resulting from theuncontrolled growth of abnormal skin cells, cause physical damage to theskin and can be deadly if left untreated. For example, roughly 120,000people in the United States are diagnosed with melanoma annually androughly 8,790 people in the United States die from the disease annually.Melanoma develops when melanocytes produce malignant tumors as a resultof overexposure to ultraviolet radiation, either from the sun orartificial lighting. Malignant tumors generally show up as large,colorful (generally dark), asymmetrical spots on the skin, thus causingdisfigurement of the skin.

Likewise, basal cell carcinoma, another type of skin cancer, is evidentfrom abnormal spots on the skin, including on the scalp of the head,which can present a variety of symptoms that affect the physicalappearance of skin and cause damage to the skin and underlying tissues.

Furthermore, demodectic mange is a dermatological condition in caninescaused by mites, resulting from an inability of a canine's immune systemto control the mites. Demodectic mange causes hair loss and can lead toa breakdown of skin, resulting in itching, scabbing, sores and otherdisfigurement of the skin and/or underlying tissues.

A puncture wound results in tissue damage, both to the skin andunderlying tissues. In some cases, excessive bleeding and infection canoccur as the result of a puncture wound. Other diseases and conditionsrelate to tissue damage, including hair loss.

Accordingly, the foregoing examples represent diseases and conditionsthat involve tissue damage, either to the skin, muscle or relatedtissues. The presently claimed invention addresses such diseases andconditions, as described herein.

SUMMARY OF THE INVENTION

One embodiment of the present invention is directed to a compositioncomprising an orthosilicate represented by Si(OR)₄, wherein R is aC₁-C₁₂ alkyl and wherein the orthosilicate is present in a concentrationfrom about 10% to about 40%. In some embodiments, R is a C₂ alkyl. Insome embodiments, the composition further comprises an oil. In someembodiments, the oil is selected from the group consisting of aloe veraoil, chamomile oil, geranium oil, jojoba oil, juniper oil, lavender oil,palm oil, sunflower oil and vanilla oil, almond oil, sweet almond oil,peanut oil, cashew oil, hazelnut oil, macadamia oil, mongongo nut oil,pecan oil, pine nut oil, pistachio oil, walnut oil, avocado oil, cocoabutter oil, coconut oil, corn oil, grapeseed oil, olive oil, sesame oil,shea butter oil and soybean oil. In some embodiments, the oil isselected from the group consisting of jojoba oil, almond oil and oliveoil. In some embodiments, the composition further comprises one or morecomponents selected from the group consisting of an excipient,stabilizer, moisturizer, thickening agent, emulsifier, emollient,lubricant, surfactant, deodorizing agent, viscosity controlling agent,solvent, softening agent, alkalizing agent, vitamin, opacifying agent,solubilizer, plant extract, water, chelating agent, humectant,thickener, cryoprotectant, biocide, nebulizer, anti-oxidant, lipid,peptide, protein, amino acid, anti-aging agent, anti-wrinkle agent,fragrance, essential oil, and preservative.

Another embodiment of the present invention is directed to a compositioncomprising essentially of an orthosilicate represented by Si(OR)₄ and anoil, wherein R is a C₁-C₁₂ alkyl and wherein the orthosilicate ispresent in a concentration from about 10% to about 40%. In someembodiments, R is a C₂ alkyl. In some embodiments, the oil is selectedfrom the group consisting of jojoba oil, almond oil and olive oil.

In yet another embodiment of the present invention is directed to acomposition comprising essentially of an orthosilicate represented bySi(OR)₄, sweet almond oil, cocoa butter and beeswax, wherein R is aC₁-C₁₂ alkyl and wherein the orthosilicate is present in a concentrationfrom about 10% to about 40%. In some embodiments, R is a C₂ alkyl. Insome embodiments, the orthosilicate is present in a concentration of20%.

Also described in the present invention is a method for treating acondition or disease requiring tissue regeneration, comprisingadministering to a subject in need thereof a composition comprising anorthosilicate represented by Si(OR)₄, wherein R is a C₁-C₁₂ alkyl andwherein the orthosilicate is present in a concentration from 10% to 40%,and a composition for treating the same. In some embodiments, R is a C₂alkyl. In some embodiments, the composition further comprises an oil. Insome embodiments, the oil is selected from the group consisting of aloevera oil, chamomile oil, geranium oil, jojoba oil, juniper oil, lavenderoil, palm oil, sunflower oil and vanilla oil, almond oil, sweet almondoil, peanut oil, cashew oil, hazelnut oil, macadamia oil, mongongo nutoil, pecan oil, pine nut oil, pistachio oil, walnut oil, avocado oil,cocoa butter oil, coconut oil, corn oil, grapeseed oil, olive oil,sesame oil, shea butter oil and soybean oil. In some embodiments, theoil is selected from the group consisting of jojoba oil, almond oil andolive oil. In some embodiments, the condition or disease is selectedfrom the group consisting of acne, a puncture wound and surface lesiondue to melanoma or basal cell carcinoma. In some embodiments, thecomposition further comprises a component selected from the groupconsisting of an excipient, stabilizer, moisturizer, thickening agent,emulsifier, emollient, lubricant, surfactant, deodorizing agent,viscosity controlling agent, solvent, softening agent, alkalizing agent,vitamin, opacifying agent, solubilizer, plant extract, water, chelatingagent, humectant, thickener, cryoprotectant, biocide, nebulizer,anti-oxidant, lipid, peptide, protein, amino acid, anti-aging agent,anti-wrinkle agent, fragrance, essential oil, and preservative.

The present invention also describes a method of preparing acomposition, comprising physically mixing an orthosilicate representedby Si(OR)₄ and an oil, wherein R is a C₁-C₁₂ alkyl and wherein theorthosilicate is present in a concentration from about 10% to about 40%.In some embodiments, R is a C₂ alkyl. In some embodiments, the oil isselected from the group consisting of aloe vera oil, chamomile oil,geranium oil, jojoba oil, juniper oil, lavender oil, palm oil, sunfloweroil and vanilla oil, almond oil, sweet almond oil, peanut oil, cashewoil, hazelnut oil, macadamia oil, mongongo nut oil, pecan oil, pine nutoil, pistachio oil, walnut oil, avocado oil, cocoa butter oil, coconutoil, corn oil, grapeseed oil, olive oil, sesame oil, shea butter oil andsoybean oil. In some embodiments, the oil is selected from the groupconsisting of jojoba oil, almond oil and olive oil. In some embodiments,the method further comprises mixing a component selected from the groupconsisting of an excipient, stabilizer, moisturizer, thickening agent,emulsifier, emollient, lubricant, surfactant, deodorizing agent,viscosity controlling agent, solvent, softening agent, alkalizing agent,vitamin, opacifying agent, solubilizer, plant extract, water, chelatingagent, humectant, thickener, cryoprotectant, biocide, nebulizer,anti-oxidant, lipid, peptide, protein, amino acid, anti-aging agent,anti-wrinkle agent, fragrance, essential oil, and preservative.

In another aspect, the present invention relates to use of thecompositions encompassed by the invention in treating a condition ordisease requiring tissue regeneration. The condition or diseaseincludes, but is not limited to, skin damages, acne, different types ofskin cancers, puncture wound, or other dermatological conditions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D depict an individual with acne before treatment with acomposition comprising orthosilicate (FIGS. 1A-1B), after 1 week oftreatment with the composition (FIG. 1C) and 4 weeks after treatmentwith the composition (FIG. 1D).

FIGS. 2A-2D depict a canine with demodectic mange prior to treatmentwith a composition comprising orthosilicate (FIGS. 2A-2B) and after 4weeks of treatment with the composition (FIGS. 2C-2D).

FIGS. 3A-3L depict an individual with basal cell carcinoma beforetreatment with a composition comprising orthosilicate (FIGS. 3A-3C), 2days after treatment with the composition (FIGS. 3D-3F), at 1 week oftreatment with the composition (FIGS. 3G-3I) and at 2 weeks of treatmentwith the composition (FIGS. 3J-3L).

FIG. 4 depicts an individual with hair regrowth after 2 months oftreatment with a composition comprising orthosilicate.

FIGS. 5A-5B depict a Beagle canine with a surface lesion due to melanomabefore treatment with a composition comprising orthosilicate (FIG. 5A)and after 7 days of treatment with the composition (FIG. 5B).

FIGS. 6A-6B depict a canine with a surface lesion due to melanoma beforetreatment with a composition comprising orthosilicate (FIG. 6A) andafter 6 days of treatment with the composition (FIG. 6B).

FIGS. 7A-7B depict a horse with a surface lesion on the tail due tomelanoma before treatment with a composition comprising orthosilicate(FIG. 7A) and after two treatments with the composition within 48 hours(FIG. 7B).

FIGS. 8A-8B depict a wound in a horse before treatment with acomposition comprising orthosilicate (FIG. 8A) and after 48 hours oftreatment with the composition and before suture (FIG. 8B).

FIGS. 9A-9B depict an infected bite wound in an adult AustralianShepherd before treatment with a composition comprising orthosilicate(FIG. 9A) and after 5 days of treatment with the composition (FIG. 9B).

FIGS. 10A-10B depict a deep laceration just above the coronary band ofthe foot in an adult Thoroughbred horse before treatment with acomposition comprising orthosilicate (FIG. 10A) and after 3 weeks oftreatment with the composition (FIG. 10B).

FIGS. 11A-11B depict an infection in the left hind foot of a heiferbefore treatment with a composition comprising orthosilicate (FIG. 11A)and after 3 weeks of treatment with the composition (FIG. 11B).

FIGS. 12A-12C depict the wound before the treatment with a compositioncomprising orthosilicate (FIG. 12A), after 10 days of treatment with thecomposition (FIG. 12B), and after 21 days of treatment with thecomposition (FIG. 12C).

DETAILED DESCRIPTION

Described herein are methods and compositions using an orthosilicate fortreating various diseases and conditions by regenerating tissue,including on the skin. Also described herein are methods for making suchcompositions.

In this specification, reference is made herein to various methodologiesknown to those of ordinary skill in the art. Publications and othermaterials setting forth such known methodologies to which reference ismade are incorporated herein by reference in their entirety as thoughset forth in full.

I. Definitions

As used herein, the singular forms “a,” “an,” and “the” designate boththe singular and the plural, unless expressly stated to designate thesingular only. Likewise, singular forms of terms designate both thesingular and plural, unless expressly stated to designate the singularonly. For example, “composition” means “composition” or “compositions.”

The term “about” in connection with numerical values and ranges meansthat the number comprehended is not limited to the exact number setforth herein, and is intended to refer to ranges substantially withinthe quoted range while not departing from the scope of the invention. Asused herein, “about” will be understood by persons of ordinary skill inthe art and will vary to some extent on the context in which it is used.

As used herein “subject” or “patient” denotes any animal in need oftreatment with a composition. For example, a subject may be sufferingfrom or at risk of developing a condition that can be treated orprevented with a composition comprising an orthosilicate. As used herein“subject” or “patient” includes humans.

As used herein, the phrases “therapeutically effective amount” and“therapeutic level” mean that dosage in a subject, respectively, thatprovides the specific response for which the composition is administeredin a subject in need of such treatment. For convenience only, exemplarydosages, delivery amounts, therapeutically effective amounts andtherapeutic levels are provided below with reference to adult humansubject. Those skilled in the art can adjust such amounts in accordancewith standard practices as needed to treat a specific subject and/orcondition/disease.

As used herein, the phrases “tissue regeneration” or “regenerate atissue” or related phrases including “tissue” and “regenerate” or“regeneration,” mean that tissue that has been damaged is being healedor has been healed. In some embodiments, these phrases also mean thatthe underlying disease or condition is being treated or has beentreated.

II. Orthosilicates

Orthosilicates useful in the compositions and methods described hereinare represented by the following formula: Si(OR)₄, wherein R is a C₁-C₁₂alkyl.

In some embodiments, compositions and methods include an orthosilicatecomprising a methyl group. In other embodiments, the compositions andmethods include an orthosilicate comprising an ethyl group. In otherembodiments, the compositions and methods include an orthosilicatecomprising a propyl group. In other embodiments, the compositions andmethods include an orthosilicate comprising an butyl group. In otherembodiments, the compositions and methods include an orthosilicatecomprising a pentyl group. In other embodiments, the compositions andmethods include an orthosilicate comprising a hexyl group. In otherembodiments, the compositions and methods include an orthosilicatecomprising an heptyl group. In other embodiments, the compositions andmethods include an orthosilicate comprising an octyl group. In otherembodiments, the compositions and methods include an orthosilicatecomprising a nonyl group. In other embodiments, the compositions andmethods include an orthosilicate comprising a decyl group. In otherembodiments, the compositions and methods include an orthosilicatecomprising an undecyl group. In other embodiments, the compositions andmethods include an orthosilicate comprising a dodecyl group.

In some embodiments, compositions and methods described herein include atetraethyl orthosilicate.

In some embodiments, the orthosilicates are present in the compositionsin a range from about 10% to about 60%, including from about 10% toabout 55%, from about 10% to about 50%, from about 10% to about 45%,from about 10% to about 40%, from about 10% to about 35%, from about 10%to about 30%, from about 10% to about 25%, from about 10% to about 20%,from about 10% to about 15%, from about 15% to about 60%, from about 15%to about 55%, from about 15% to about 50%, from about 15% to about 45%,from about 15% to about 40%, from about 15% to about 35%, from about 15%to about 30%, from about 15% to about 25%, from about 15% to about 20%,from about 20% to about 60%, from about 20% to about 55%, from about 20%to about 50%, from about 20% to about 45%, from about 20% to about 40%,from about 20% to about 35%, from about 20% to about 30%, from about 20%to about 25%, from about 25% to about 60%, from about 25% to about 55%,from about 25% to about 50%, from about 25% to about 45%, from about 25%to about 40%, from about 25% to about 35%, from about 25% to about 30%,from about 30% to about 60%, from about 30% to about 55%, from about 30%to about 50%, from about 30% to about 45%, from about 30% to about 40%,from about 30% to about 35%, from about 35% to about 60%, from about 35%to about 55%, from about 35% to about 50%, from about 35% to about 45%,from about 35% to about 40%, from about 40% to about 60%, from about 40%to about 55%, from about 40% to about 50%, from about 40% to about 45%,from about 45% to about 60%, from about 45% to about 55%, from about 45%to about 50%, from about 50% to about 60%, from about 50% to about 55%,from about 55% to about 60%, such as about 10%, about 15%, about 20%,about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about55% and about 60%.

In some embodiments, the orthosilicates are present in the compositionin a range from 10% to 60%, including from 10% to 55%, from 10% to 50%,from 10% to 45%, from 10% to 40%, from 10% to 35%, from 10% to 30%, from10% to 25%, from 10% to 20%, from 10% to 15%, from 15% to 60%, from 15%to 55%, from 15% to 50%, from 15% to 45%, from 15% to 40%, from 15% to35%, from 15% to 30%, from 15% to 25%, from 15% to 20%, from 20% to 60%,from 20% to 55%, from 20% to 50%, from 20% to 45%, from 20% to 40%, from20% to 35%, from 20% to 30%, from 20% to 25%, from 25% to 60%, from 25%to 55%, from 25% to 50%, from 25% to 45%, from 25% to 40%, from 25% to35%, from 25% to 30%, from 30% to 60%, from 30% to 55%, from 30% to 50%,from 30% to 45%, from 30% to 40%, from 30% to 35%, from 35% to 60%, from35% to 55%, from 35% to 50%, from 35% to 45%, from 35% to 40%, from 40%to 60%, from 40% to 55%, from 40% to 50%, from 40% to 45%, from 45% to60%, from 45% to 55%, from 45% to 50%, from 50% to 60%, from 50% to 55%,from 55% to 60%, such as 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%,55% and 60%.

In some embodiments, the orthosilicates present in compositionsdescribed herein do not polymerize after contact with an aqueousenvironment, such as an in vivo environment. Without being bound bytheory, it is believed that the lack of such polymerization allows theorthosilicates to effectively treat a disease or condition byregenerating tissue.

Also without being bound by theory, it is believed that the compositionsdescribed herein regenerate tissue by activating the innate immunesystem, thus inducing the body to produce a response to tissue damageand assist in the regeneration of tissue.

In this regard, macrophages, the principal action cell of the innateimmune system, targets cells that display markers in the form ofpathogen associated molecular profiles (pamp's) or damage associatedmolecular profiles (damp's) on their membrane surface. The macrophageswill phagocytize cells displaying such markers. Such phagocytic activityis also associated with the release of chemokines from the activatedmacrophages, which further attracts more monocytes that in turndifferentiate into more macrophages, flooding the sites where cellsdisplaying pamp's or damp's are present. Not only will this flood ofmacrophages clear any nearby pathogens and/or diseased or dying cells,but also, once any such cells are destroyed, the entire gene expressionprofile of these macrophages changes so that the macrophages becomeengaged in tissue remodeling and repair.

Thus, it is believed that orthosilicates interact with the externalmembranes of damaged or dying cells to decorate these cells such thatthey now display dramatically “super” damp's that maximally activatemacrophages and maximally trigger the above-stated response. It is alsobelieved that even perfectly normal tissue (e.g., normal skin) containdying cells, so orthosilicates interact with triggering therepair/remodeling response to produce tissue regeneration in manyapplications (e.g., for cosmetic applications).

In some embodiments, the compositions described herein include water. Inother embodiments, the compositions described herein to not includewater.

III. Oils

Oils suitable for use in the compositions and methods described hereininclude oils derived from a plant, flower, nut, fruit, seed andvegetable.

In some embodiments, the compositions include one or more of thefollowing oils derived from a plant or flower: aloe vera oil, chamomileoil, geranium oil, jojoba oil, juniper oil, lavender oil, palm oil,sunflower oil and vanilla oil.

In other embodiments, the compositions include one or more of thefollowing oils derived from a nut: almond oil, sweet almond oil, peanutoil, cashew oil, hazelnut oil, macadamia oil, mongongo nut oil, pecanoil, pine nut oil, pistachio oil and walnut oil.

In other embodiments, the compositions include one or more oils derivedfrom a fruit, seed or vegetable: avocado oil, cocoa butter oil, coconutoil, corn oil, grapeseed oil, olive oil, sesame oil, shea butter oil andsoybean oil.

In some embodiments, an oil suitable for the compositions describedherein is a hydrophobic medium. In some embodiments, the oil is a longchain alcohol or acid.

The oils can be included in the compositions in an amount of from about10% to about 90%, including about 10% to about 85%, about 10% to about80%, about 10% to about 75%, about 10% to about 70%, about 10% to about65%, about 10% to about 60%, about 10% to about 55%, about 10% to about50%, about 10% to about 45%, about 10% to about 40%, about 10% to about35%, about 10% to about 30%, about 10% to about 25%, about 10% to about20%, about 10% to about 15%, about 15% to about 90%, about 15% to about85%, about 15% to about 80%, about 15% to about 75%, about 15% to about70%, about 15% to about 65%, about 15% to about 60%, about 15% to about55%, about 15% to about 50%, about 15% to about 45%, about 15% to about40%, about 15% to about 35%, about 15% to about 30%, about 15% to about25%, about 15% to about 20%, about 20% to about 90%, about 20% to about85%, about 20% to about 80%, about 20% to about 75%, about 20% to about70%, about 20% to about 65%, about 20% to about 60%, about 20% to about55%, about 20% to about 50%, about 20% to about 45%, about 20% to about40%, about 20% to about 35%, about 20% to about 30%, about 20% to about25%, about 25% to about 90%, about 25% to about 85%, about 25% to about80%, about 25% to about 75%, about 25% to about 70%, about 25% to about65%, about 25% to about 60%, about 25% to about 55%, about 25% to about50%, about 25% to about 45%, about 25% to about 40%, about 25% to about35%, about 25% to about 30%, about 30% to about 90%, about 30% to about85%, about 30% to about 80%, about 30% to about 75%, about 30% to about70%, about 30% to about 65%, about 30% to about 60%, about 30% to about55%, about 30% to about 50%, about 30% to about 45%, about 30% to about40%, about 30% to about 35%, about 35% to about 90%, about 35% to about85%, about 35% to about 80%, about 35% to about 75%, about 35% to about70%, about 35% to about 65%, about 35% to about 60%, about 35% to about55%, about 35% to about 50%, about 35% to about 45%, about 35% to about40%, about 40% to about 90%, about 40% to about 85%, about 40% to about80%, about 40% to about 75%, about 40% to about 70%, about 40% to about65%, about 40% to about 60%, about 40% to about 55%, about 40% to about50%, about 40% to about 45%, about 45% to about 90%, about 45% to about85%, about 45% to about 80%, about 45% to about 75%, about 45% to about70%, about 45% to about 65%, about 45% to about 60%, about 45% to about55%, about 45% to about 50%, about 50% to about 90%, about 50% to about85%, about 50% to about 80%, about 50% to about 75%, about 50% to about70%, about 50% to about 65%, about 50% to about 60%, about 50% to about55%, about 55% to about 90%, about 55% to about 85%, about 55% to about80%, about 55% to about 75%, about 55% to about 70%, about 55% to about65%, about 55% to about 60%, about 60% to about 90%, about 60% to about85%, about 60% to about 80%, about 60% to about 75%, about 60% to about70%, about 60% to about 65%, about 65% to about 90%, about 65% to about85%, about 65% to about 80%, about 65% to about 75%, about 65% to about70%, about 70% to about 90%, about 70% to about 85%, about 70% to about80%, about 70% to about 75%, about 75% to about 90%, about 75% to about85%, about 75% to about 80%, about 80% to about 90%, about 80% to about85%, about 85% to about 90%, such as about 10%, about 15%, about 20%,about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%and about 90%.

The oils can be included in the compositions in an amount of from 10% to90%, including 10% to 85%, 10% to 80%, 10% to 75%, 10% to 70%, 10% to65%, 10% to 60%, 10% to 55%, 10% to 50%, 10% to 45%, 10% to 40%, 10% to35%, 10% to 30%, 10% to 25%, 10% to 20%, 10% to 15%, 15% to 90%, 15% to85%, 15% to 80%, 15% to 75%, 15% to 70%, 15% to 65%, 15% to 60%, 15% to55%, 15% to 50%, 15% to 45%, 15% to 40%, 15% to 35%, 15% to 30%, 15% to25%, 15% to 20%, 20% to 90%, 20% to 85%, 20% to 80%, 20% to 75%, 20% to70%, 20% to 65%, 20% to 60%, 20% to 55%, 20% to 50%, 20% to 45%, 20% to40%, 20% to 35%, 20% to 30%, 20% to 25%, 25% to 90%, 25% to 85%, 25% to80%, 25% to 75%, 25% to 70%, 25% to 65%, 25% to 60%, 25% to 55%, 25% to50%, 25% to 45%, 25% to 40%, 25% to 35%, 25% to 30%, 30% to 90%, 30% to85%, 30% to 80%, 30% to 75%, 30% to 70%, 30% to 65%, 30% to 60%, 30% to55%, 30% to 50%, 30% to 45%, 30% to 40%, 30% to 35%, 35% to 90%, 35% to85%, 35% to 80%, 35% to 75%, 35% to 70%, 35% to 65%, 35% to 60%, 35% to55%, 35% to 50%, 35% to 45%, 35% to 40%, 40% to 90%, 40% to 85%, 40% to80%, 40% to 75%, 40% to 70%, 40% to 65%, 40% to 60%, 40% to 55%, 40% to50%, 40% to 45%, 45% to 90%, 45% to 85%, 45% to 80%, 45% to 75%, 45% to70%, 45% to 65%, 45% to 60%, 45% to 55%, 45% to 50%, 50% to 90%, 50% to85%, 50% to 80%, 50% to 75%, 50% to 70%, 50% to 65%, 50% to 60%, 50% to55%, 55% to 90%, 55% to 85%, 55% to 80%, 55% to 75%, 55% to 70%, 55% to65%, 55% to 60%, 60% to 90%, 60% to 85%, 60% to 80%, 60% to 75%, 60% to70%, 60% to 65%, 65% to 90%, 65% to 85%, 65% to 80%, 65% to 70%, 70% to90%, 70% to 85%, 70% to 80%, 70% to 75%, 75% to 90%, 75% to 85%, 75% to80%, 80% to 90%, 80% to 85%, 85% to 90%, such as 10%, 15%, 20%, 25%,30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85% and 90%.

Without being bound by theory, it is believed that the orthosilicates,when administered to a subject in the presence of oil in thecompositions described herein, become protected inside a micelle formedby the oil in the presence of surfactants, either naturally within thetissue or added in the composition. In some embodiments, such protectionleads to the ability of the orthosilicates to regenerate tissue in vivo.

III. Compositions

Described herein are compositions comprising one or more orthosilicatesand oils, as described herein. The compositions can include one or moreorthosilicates and oils in the same or different compositions foradministration to a subject. In some preferred embodiments, one or moreorthosilicates and one or more oils are contained in the samecomposition. In other embodiments, one or more orthosilicates and one ormore oils are separately applied.

In some embodiments, the compositions described herein include one ormore additional components, such as a diluent, penetration enhancer,excipient, stabilizer, moisturizer, thickening agent, emulsifier,emollient, lubricant, surfactant, deodorizing agent, viscositycontrolling agent (such as a viscosity increasing agent and a viscositydecreasing agent), solvent, softening agent, alkalizing agent (includingto adjust pH), vitamin, opacifying agent, solubilizer, plant extract,water (including purified water), chelating agent, humectant, thickener,cryoprotectant, biocide, adjuvant, nebulizer, anti-oxidant, lipid,peptide, protein, amino acid, anti-aging agent, anti-wrinkle agent,fragrance, essential oil, preservative, and combinations thereof.

In some embodiments, the compositions described herein include one ormore additional components, such as Isopropyl Palmitate, Lecithin,C12-15 Alkyl Benzoate, Cetyl Alcohol, Cetearyl Alcohol,Ethylhexylglycerin, Glycerin USP, Glyceryl Stearate, HydroxyethylAcrylate/Sodium, Acryloyldimethyl Taurate Copolymer, Oleic Acid, PEG 100Stearate, Phenoxyethanol, Polymethylsiloxane, Purified Water, StearicAcid, Trolamine NF, Vitamin E, Vitamin E Acetate, Ethylhexyl Stearate,Glycerol Stearate, PEG 100 Stearate, Polysorbate-60, Aloe, Leaf Juice,EDTA, Sorbitol, Cyclomethicone, Isothiazolinone, Propylene Glycol,Ceteareth 20, Dimethicone, Octyldodecanol, Phenoxyethanol, Bees wax andcombinations thereof.

The one or more additional components can be included in the compositionin an amount from about 10% to about 80%, about 10% to about 75%, about10% to about 70%, about 10% to about 65%, about 10% to about 60%, about10% to about 55%, about 10% to about 50%, about 10% to about 45%, about10% to about 40%, about 10% to about 35%, about 10% to about 30%, about10% to about 25%, about 10% to about 20%, about 10% to about 15%, about15% to about 80%, about 15% to about 75%, about 15% to about 70%, about15% to about 65%, about 15% to about 60%, about 15% to about 55%, about15% to about 50%, about 15% to about 45%, about 15% to about 40%, about15% to about 35%, about 15% to about 30%, about 15% to about 25%, about15% to about 20%, about 20% to about 80%, about 20% to about 75%, about20% to about 70%, about 20% to about 65%, about 20% to about 60%, about20% to about 55%, about 20% to about 50%, about 20% to about 45%, about20% to about 40%, about 20% to about 35%, about 20% to about 30%, about20% to about 25%, about 25% to about 80%, about 25% to about 75%, about25% to about 70%, about 25% to about 65%, about 25% to about 60%, about25% to about 55%, about 25% to about 50%, about 25% to about 45%, about25% to about 40%, about 25% to about 35%, about 25% to about 30%, about30% to about 80%, about 30% to about 75%, about 30% to about 70%, about30% to about 65%, about 30% to about 60%, about 30% to about 55%, about30% to about 50%, about 30% to about 45%, about 30% to about 40%, about30% to about 35%, about 35% to about 80%, about 35% to about 75%, about35% to about 70%, about 35% to about 65%, about 35% to about 60%, about35% to about 55%, about 35% to about 50%, about 35% to about 45%, about35% to about 40%, about 40% to about 80%, about 40% to about 75%, about40% to about 70%, about 40% to about 65%, about 40% to about 60%, about40% to about 55%, about 40% to about 50%, about 40% to about 45%, about45% to about 80%, about 45% to about 75%, about 45% to about 70%, about45% to about 65%, about 45% to about 60%, about 45% to about 55%, about45% to about 50%, about 50% to about 80%, about 50% to about 75%, about50% to about 70%, about 50% to about 65%, about 50% to about 60%, about50% to about 65%, about 50% to about 60%, about 50% to about 55%, about55% to about 80%, about 55% to about 75%, about 55% to about 70%, about55% to about 65%, about 55% to about 60%, about 60% to about 80%, about60% to about 75%, about 60% to about 70%, about 60% to about 65%, about65% to about 80%, about 65% to about 75%, about 65% to about 70%, about70% to about 80%, about 70% to about 75%, about 75% to about 80%, suchas about 10%, about 15%, about 20%, about 25%, about 30%, about 35%,about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about70%, about 75% and about 80%.

The one or more additional components can be included in thecompositions in an amount of from 10% to 80%, 10% to 75%, 10% to 70%,10% to 65%, 10% to 60%, 10% to 55%, 10% to 50%, 10% to 45%, 10% to 40%,10% to 35%, 10% to 30%, 10% to 25%, 10% to 20%, 10% to 15%, 15% to 80%,15% to 75%, 15% to 70%, 15% to 65%, 15% to 60%, 15% to 55%, 15% to 50%,15% to 45%, 15% to 40%, 15% to 35%, 15% to 30%, 15% to 25%, 15% to 20%,20% to 80%, 20% to 75%, 20% to 70%, 20% to 65%, 20% to 60%, 20% to 55%,20% to 50%, 20% to 45%, 20% to 40%, 20% to 35%, 20% to 30%, 20% to 25%,25% to 80%, 25% to 75%, 25% to 70%, 25% to 65%, 25% to 60%, 25% to 55%,25% to 50%, 25% to 45%, 25% to 40%, 25% to 35%, 25% to 30%, 30% to 80%,30% to 75%, 30% to 70%, 30% to 65%, 30% to 60%, 30% to 55%, 30% to 50%,30% to 45%, 30% to 40%, 30% to 35%, 35% to 80%, 35% to 75%, 35% to 70%,35% to 65%, 35% to 60%, 35% to 55%, 35% to 50%, 35% to 45%, 35% to 40%,40% to 80%, 40% to 75%, 40% to 70%, 40% to 65%, 40% to 60%, 40% to 55%,40% to 50%, 40% to 45%, 45% to 80%, 45% to 75%, 45% to 70%, 45% to 65%,45% to 60%, 45% to 55%, 45% to 50%, 50% to 80%, 50% to 75%, 50% to 70%,50% to 65%, 50% to 60%, 50% to 65%, 50% to 60%, 50% to 55%, 55% to 80%,55% to 75%, 55% to 70%, 55% to 65%, 55% to 60%, 60% to 80%, 60% to 75%,60% to 70%, 60% to 65%, 65% to 80%, 65% to 75%, 65% to 70%, 70% to 80%,70% to 75%, 75% to 80%, such as 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%,50%, 55%, 60%, 65%, 70%, 75% and 80%.

IV. Methods of Making

The compositions described herein can be presented in different forms.In one embodiment, the compositions are presented for topicalapplication, such as a cosmetic. In another embodiment, the compositionsare presented as a cream. In another embodiment, the compositions arepresented as a gel. In another embodiment, the compositions arepresented as a lotion. In another embodiment, the compositions arepresented as an ointment. In another embodiment, the compositions arepresented as a paste. In another embodiment, the compositions arepresented as a patch. In another embodiment, the compositions arepresented as soaps.

In one embodiment, the compositions are prepared by combining one ormore orthosilicates with one or more oils and physically mixing theorthosilicate(s) and oil(s). In another embodiment, the compositions areprepared by combining one or more orthosilicates with one or more oilsand one or more additional components, including optionally water, andphysically mixing the orthosilicate(s), oil(s), additional component(s)and optionally water.

V. Methods of Use

The compositions as described herein are useful for treating a varietyof diseases and conditions. As described herein, the compositions areuseful for remodeling tissue, including the skin.

In some embodiments, the compositions are useful as topicalapplications, such as for cosmetic applications. In some embodiments,the compositions are useful as pharmaceutical applications.

As described herein, the compositions are useful for treating tissuedamage. In some embodiments, the compositions are useful for treating aphysical wound, scarring and a dermatological condition, such as acne,demodectic mange and surface lesion from skin cancer, such as melanomaand basal cell carcinoma.

In some embodiments, the compositions are applied by topicaladministration onto a body surface, including the skin, nail, or mucosa.In some embodiments, the compositions are topically applied by smearingor rubbing the compositions onto the body surface. In some embodiments,the compositions are sprayed onto the body surface. In other someembodiments, the compositions are administered by droplet(s) from adispenser, such as a syringe or eye dropper.

In some embodiments, the compositions described herein are applied once.In other embodiments, the compositions are applied multiple times,including applied multiple times a day for multiple days. For example,the compositions can be applied for 1, 2, 3, 4, 5, 6 or 7 or more days,such as for 1, 2, 3, 4, 5, 6, or 7 or more days.

In some embodiments, the compositions are applied multiple times for twoweeks, such as 1, 2, 3, 4 or 5 times daily for up to two weeks. Forexample, the compositions can be applied 1, 2, 3, 4 or 5 times daily forup to one or two months. In other embodiments, the compositions areapplied once or multiple times a day until the disease or conditionbeing treated has been removed.

In some embodiments, the compositions described herein are administeredwith another active agent. In other embodiments, the compositionsdescribed herein are not administered with another active agent.

VI. Examples

The following examples are merely demonstrative and highlight theorthosilicate compounds and methods of making and methods of using suchcompounds, as described herein.

EXAMPLE 1

A formulation (Formulation 1) containing orthosilicate was producedaccording to the methods described herein:

-   -   1. C12-15 Alkyl Benzoate    -   2. Caprylic/Capric Triglycerides    -   3. Cetyl Alcohol    -   4. Ethylhexylglycerin    -   5. Glycerin USP    -   6. Glyceryl Stearate    -   7. Hydroxyethyl Acrylate/Sodium    -   8. Acryloyldimethyl Taurate Copolymer    -   9. Oleic Acid    -   10. Olive Oil    -   11. PEG 100 Stearate    -   12. Phenoxyethanol    -   13. Polymethylsiloxane    -   14. Purified Water    -   15. Stearic Acid    -   16. Trolamine NF    -   17. Vitamin E Acetate    -   18. Tetraethyl Ortho silicate

EXAMPLE 2

A formulation (Formulation 2) containing orthosilicate was producedaccording to the methods described herein:

-   -   1. Purified Water    -   2. Ethylhexyl Stearate    -   3. Cetearyl Alcohol    -   4. Polysorbate-60    -   5. Aloe    -   6. Leaf Juice    -   7. Vitamin E    -   8. EDTA    -   9. Sorbitol    -   10. Cyclomethicone    -   11. Isothiazolinone    -   12. Tetraethyl Orthosilicate

EXAMPLE 3

A formulation (Formulation 3) containing orthosilicate was producedaccording to the methods described herein:

-   -   1. Purified Water    -   2. Isopropyl Palmitate    -   3. Caprylic/Capric Triglyceride    -   4. Propylene Glycol    -   5. Ceteareth 20    -   6. Cetearyl Alcohol    -   7. Glycerol Stearate    -   8. PEG 100 Stearate    -   9. Dimethicone    -   10. Octyldodecanol    -   11. Lecithin    -   12. Ethylhexylglycerin    -   13. Phenoxyethanol    -   14. Tetraethyl Orthosilicate

EXAMPLE 4

A formulation (Formulation 4) containing orthosilicate was producedaccording to the methods described herein:

-   -   1. Jojoba oil    -   2. Tetraethyl Orthosilicate

EXAMPLE 5

A formulation (Formulation 5) containing orthosilicate was producedaccording to the methods described herein:

-   -   1. Cocoa butter    -   2. Bees wax    -   3. Sweet Almond Oil    -   4. Orthosilicate

EXAMPLE 6

A cosmetic formulation (Formulation 6) containing orthosilicate wasproduced according to the methods described herein. The ingredients andthe amount for each ingredient in weight percentage are detailed inTable 1 below.

TABLE 1 Cosmetic Formulation Amount Part Ingredient (% w/w) A Distilledwater 40.73 A Sodium chloride 1.00 A Phytic acid (e.g., Phytic AcidExtreme from 0.25 Biosil Technologies, Inc.) A Citric acid 0.01 A Aloebarbadensis leaf juice 0.10 A Coco-Glucoside, Glyceryl Oleate(Lamesoft ® PO 65) 2.00 A Cocamidopropyl PG-Dimonium Chloride Phosphate0.20 (Cola ® Lipid C) B Crodafos ™ CES (Blend of Cetearyl Alcohol, 5.20Dicetyl Phosphate, Ceteth-10 Phosphate) B C12-15 Alkyl Benzoate(Tegosoft ® TN 2) 10.00 B Stearoxytrimethylsilane (SilCare Silicone ®1M71) 10.00 B Cetearyl Alcohol (Crodacol ™ 1618) 0.10 B Glyceryl Oleate(Tegin ® O V) 0.10 B Vinyl Dimethicone/Methicone Silsesquioxane 5.00crosspolymer (KSP-100) C Sodium hydroxide (10%) 1.54 C IDEALIFT ™ (Blendof Butylene Glycol, 2.00 Water, Sorbitan Laurate, Hydroxyethylcelluloseand Acetyl Dipeptide-1 Cetyl Ester) C Arginine 0.10 C Bisabolol 0.05 CFragrance extract blend (Sensique Ginger Euxyl 9010) 0.20 CPhenoxyethanol, Ethylhexylglycerine 1.00 D Tetraethoxysilane 10.00 DPropylene Glycol 1.00 D Glycerin 2.00 D Dimethyl Isosorbide (Arlasolve ™DMI) 0.20 D Polysorbate 20 (Tween 20) 4.00 E Sodium Citrate 0.12 EMPC ™ - Milk Peptide Complex (whey protein) 0.10 E Distilled water 3.00

Formulation 6 was prepared as follows: the ingredients of Part A andPart B were combined and mixed separately, and each was heated withmixing to about 75° C. Then Part B was added to Part A with mixing, andmixing was continued for 15-20 minutes, until cooled to about 40° C.Part C was then added. Ingredients of Part D and Part E were premixedseparately and each was added to the batch. The mixture was homogenizeduntil uniform.

EXAMPLE 7

Formula 5 from Example 5 was prepared as a cream in the followingratios: 20% tetraethyl orthosilicate; and equal amounts of cocoa butter,bees wax and sweet almond oil. To prepare the cream, the bees wax wasmelted and then combined with the sweet almond oil, cocoa butter andorthosilicate to produce a final concentration of 20% orthosilicate.

The prepared cream was applied to the face of a patient suffering fromacne once every evening for 4 weeks.

FIGS. 1A-1B depicts the face of the patient before starting the 4-weekperiod. FIG. 1B is a close-up of the patient's forehead, clearlydepicting the presence of acne.

FIG. 1C depicts the forehead of the patient 1-week after initiatingtreatment with the cream. This figure demonstrates that the once-a-nightapplication of the cream reduced the presence of the acne.

FIG. 1D depicts the face of the patient after completion of the 4-weekperiod. This figure, combined with FIGS. 1A-1C, demonstrate that a creamcomposition containing orthosilicate significantly reduced the visibleimpact of acne on the patient's face.

EXAMPLE 8

A composition containing 40% tetraethyl orthosilicate and 60% olive oilby volume was prepared by physical mixing. The composition wasadministered to a canine suffering from demodectic mange twice a day for4 weeks.

FIGS. 2A and 2B show the canine prior to treatment with the composition.FIGS. 2C and 2D show the canine after 4 weeks of treatment. Thesefigures demonstrates that the composition containing a mixture of 40%tetraethyl orthosilicate and 60% olive oil was able to successfullytreat demodectic mange in a canine

EXAMPLE 9

A composition containing 40% tetraethyl orthosilicate and 60% jojoba oilby volume was prepared by physical mixing. The composition wasadministered to the forehead of a human patient suffering from basalcell carcinoma twice a day for a period of 2 weeks.

FIGS. 3A-3C depict the forehead of the patient before treatment. FIGS.3D-3F show the forehead after 2 days of treatment. FIGS. 3G-3I show theforehead at 1 week of treatment. FIGS. 3J-3L show the forehead at twoweeks of treatment. These figures demonstrate that a compositioncontaining a mixture of 40% tetraethyl orthosilicate and 60% jojoba oilis capable of performing tissue regeneration in a patient suffering frombasal cell carcinoma.

EXAMPLE 10

A composition containing 40% tetraethyl orthosilicate and 60% jojoba oilwas administered to the scalp of a person lacking hair at the place ofadministration. The composition was administered once daily for 2months.

FIG. 4 depicts the scalp of the person after 2 months of treatment. Atthe place of administration, new hair grew. Surprisingly, the new growthwas pigmented and not white like the surrounding, existing hair.

EXAMPLE 11

A weanling Thoroughbred filly presented with a full skin thicknesslaceration (approx 3 inches) of the upper right forearm and multiplecontusions and abrasions on the leg, as well as on the body and head.

The filly was treated by first undergoing sedation, its injuries lavagedwith isotonic fluids, the wound edges trimmed, and then an ointment wasapplied to the laceration and other injuries. The ointment contained thefollowing components: 100 ml polyethylene glycol 400; 50 g. polyethyleneglycol 3540; 5.6 g. salicylic acid; 11 g. benzoic acid; 115 mltetraethyl orthosilicate; and 10 ml methyl alcohol. The wound wassutured with horizontal mattress sutures. Phenylbutazone and systemicantibiotic was given to the filly.

The filly was confined to a stall for 10 days with daily application ofthe ointment to the injuries, combined with an oral antibiotic (7 days).The suture was removed at two weeks after several days of turn out.

After the 10-day period, the wound healed uneventfully withoutcomplication and the other injuries healed. Hair re-growth was alsobegan quickly.

EXAMPLE 12

A yearling Thoroughbred filly presented with a Y-shaped full skinthickness laceration of the left chest (at least 6 inches) with a looseflap. The laceration was cleaned and sutured with a simple continuoussuture pattern. The filly was also treated with systemic antibiotics.After 5 days, however, wound dehiscence with purulent discharge wasevident.

After discovering the wound dehiscence and purulent discharge, the woundwas subsequently cleaned and lavaged using an isotonic solution andpacked with the ointment from Example 11. The antibiotic treatment wasalso continued. The combination of the ointment and antibiotic treatmentwas repeated daily for 2 additional days. Afterwards, loop sutures wereplaced above and below the wound, loose sutures were removed and thewound was lavaged with the ointment in isotonic solution, covered withthe ointment and a bandage laced in place using loops.

After 24 hours, the bandage was removed and a dramatic improvement withseen, evident by a healthy granulating bed of tissue developing. After 3additional days of treatment with the ointment, a horizontal mattressstay suture over rubber tubing was applied to oppose the tissues, andthe wound was treated and re-bandaged with the ointment. The bandagewith the ointment was reapplied daily for 2 more days. The wound wassubsequently lavaged with additional ointment, trimmed, sutured withhorizontal mattress sutures after application of the ointment andrebandaged.

After the foregoing treatment and inspection of the filly, it wasevidence that granulation and wound healing was accelerated, andinfection was eliminated.

EXAMPLE 13

A mature Quarter Horse mare presented with a deep wood puncture of theleft buttock and a deep laceration involving the left side of the vulvaextending between the hind legs to the udder. The wounds wereapproximately 6 inches deep with a large vulgar flap.

The mare was sedated, the wound was cleaned and the wood was removed.Phenylbutazone and antibiotic given to the mare. After 4 days, the woundwas trimmed of necrotic, devitilized tissue and the ointment fromExample 11 was applied.

The wound was subsequently cleaned daily and the ointment applied as theonly treatment. No infection or discharge was observed and the woundshealed at an accelerated rate from the inside out.

After 3 weeks, the wound was healing nicely with only superficial (lessthan 1 inch depth) wound remaining No lameness or restriction ofmovement was observed, which resulted in a much better than expectedprogress. A full recovery is expected based on this observation.

EXAMPLE 14

A yearling Thoroughbred filly presented with a developing mass (suspectsarcoid) on the midline of the face, approximately 1 inch in diameter.

The ointment from Example 11 was applied daily, resulting in a visible“breakdown” and resorption of the mass over approximately a 1-monthperiod. The mass has not reoccurred despite no further treatment after 1month.

EXAMPLE 15

A Beagle diagnosed with melanoma was administered with a compositioncontaining 40% tetraethyl orthosilicate and 60% jojoba oil by directapplication to the surface lesion over a period of 7 days, three timesdaily, using a cotton swab. FIG. 5A depicts the surface lesion on day 1of treatment and FIG. 5B depicts the surface lesion on day 7 of thetreatment. These figures demonstrate that the composition reduced themelanoma lesion.

EXAMPLE 16

A composition comprising orthosilicate can be produced in the followingmanner: melt 10 g. of natural unbleached beeswax, 20 g. of cocoa butter(100% natural) and 20 g. of almond oil together to produce a homogenousmixture with warm, liquid consistency. Then, add 20 g. of tetraethylorthosilicate to the mixture and cool the mixture with occasionalstirring until a cream forms. Greater stirring will yield a lightercream. The cream can be aliquoted into containers.

EXAMPLE 17

A composition comprising orthosilicate can be produced in the followingmanner: dissolve 3 liters of tetraethyl orthosilicate in 2 liters ofabsolute methanol. Then, add 1.12 kg. of salicylic acid and 2.2 kg. ofbenzoic acid to the suspension and heat the mixture to 140° F. withstirring until more than 50% of the acids dissolve. At this point, add20 liters of polyethyleneoxide (400 MW) and continue stirring at thesame temperature of 140° F. until a complete solution occurs. Then,while maintaining the temperature of 140° F., add 10 kg. of polyethyleneoxide (3500-3700 MW) to the solution and stir until a clear solutiondevelops Aliquot the solution, which should be warm, into containers andallow the solution to cool to produce a gel formation. The gel can beused to treat different diseases and conditions, such as an open wound,including a puncture wound.

EXAMPLE 18

A cream composition comprising orthosilicate was produced in thefollowing manner: 40 grams of CRODAFOS™ CES and 60 grams of myristylmyristate were mixed well at a temperature of about 75° C. to obtainPart A. The following ingredients at the specific amounts were mixedwell: 7 grams of glycerine, 50 grams of caprylyl carbonate, 10.5 gramsof aloe vera (10×), 30 grams of dihydroxypropane, 5 grams of glyceryloleate, 632 grams of 75° C. hot water, 2.5 grams of phenoxyethanol andethylhexylglycerin, and 13 grams of arginine to adjust pH to pH 8 toobtain Part B. Part A was added to Part B and mixed well, followed by acheck of the pH. Subsequently, 125 grams of tetraethyl orthosilicate wasadded to the mixture of Part A and Part B and mixed well to obtain thecream. Then Q/S with water.

EXAMPLE 19

The cream produced in Example 18 can be used in treating human scar,melanoma, or basal cell carcinoma. For example, the cream of Example 18can be applied to a scar, twice daily, for two weeks or more.

EXAMPLE 20

A canine diagnosed with melanoma was administered with the cream ofExample 18 by direct application to the surface lesion over a period of6 days, two or three times daily, using a cotton swab. FIG. 6A depictsthe surface lesion prior to treatment and FIG. 6B depicts the surfacelesion on day 6 after the treatment. These figures demonstrate that thecream reduced the melanoma lesion.

EXAMPLE 21

A horse diagnosed with melanoma on its tail was administered twotreatments of the cream of Example 18 over a period of 48 hours. FIG. 7Adepicts the surface lesion on the tail prior to treatment and FIG. 7Bdepicts the surface lesion after two treatments within 48 hours. Asshown in FIG. 7B, the lesions started sloughing off within 48 hours.

EXAMPLE 22

The cream of Example 18 was administered to an open wound in a horseover a period of 48 hours. FIG. 8A depicts the wound after initialtreatment with standard therapy and FIG. 8B depicts the wound after 48hours of treatment with the cream of Example 18 and before suture.

EXAMPLE 23

The cream of Example 18 was applied daily for 5 days to an adultAustralian Shepherd presented with an infected bite wound approximately1″×1½″ with purulent discharge. FIG. 9A depicts the original bite siteand FIG. 9B depicts the wound after 5 days of treatment with the creamof Example 18. The treatment resulted in complete healing without anyscar.

EXAMPLE 24

An adult Thoroughbred horse was presented with a deep laceration justabove the coronary band of the foot. This was a very difficult area toheal due to contamination and movement of the tissues. The wound wascleaned daily with water and bandaged with the cream of Example 18 for 3weeks. FIG. 10A depicts the wound before treatment and FIG. 10B depictsthe wound after 3 weeks of treatment with the cream of Example 18. Thewound healed uneventfully without scarring or lameness after thetreatment.

EXAMPLE 25

A two-year old female American Shorthorn heifer was presented withlameness and a proliferative mass (3″ in diameter)with associatedswelling and large dense scab between the digits of the left hind footdiagnosed as chronic Foot Rot. The heifer was treated with a 7-daycourse of oral antibiotic with some improvement in swelling and lamenessbut the scabbing and proliferative area remained. After 4 monthslameness reoccurred and the area again became inflamed. The heifer wastreated with Nuflor (an injectable antibiotic) for 7 days with reductionof mass size by approximately ⅓ and reduced lameness. A surgicalconsultation determined that the area needed to be surgically excisedunder general anesthesia. Due to late term pregnancy, surgery waspostponed until after delivery. While waiting for surgery, the cream ofExample 18 was applied once daily by massaging the cream into the areabetween the digits. Within the first week, the lesion began to reduce insize and the scabbing loosened allowing the cream to be worked under it.After 2 weeks, the scab came off and the lesion was reduced by at least75% with no associated lameness. At week 3, the lesion was barelynoticeable with no lameness. No surgery or further antibiotic therapywas anticipated. FIG. 11A depicts the infection in the left hind footbefore treatment and FIG. 11B depicts the infected area after 3 weeks oftreatment with the cream of Example 18.

This successful treatment was significant because it resulted insignificant reduction in cost and risk by eliminating the need forsurgery and general anesthesia.

EXAMPLE 26

A yearling Thoroughbred filly presented with a developing mass (suspectsarcoid) on the midline of the face approximately 1 inch in diameter.The filly was treated by daily application of the cream of Example 18.The treatment resulted in a visible “breakdown” and resorption of themass over approximately one-month period. After the one-month treatment,no further treatment was required as the mass did not reoccur.

EXAMPLE 27

A weanling Thoroughbred filly presented with a full skin thicknesslaceration (approx 3 inches) of the upper right forearm and multiplecontusions and abrasions on the leg, as well as on the body and head.

The filly was treated by first undergoing sedation, its injuries lavagedwith isotonic fluids, the wound edges trimmed, and then the cream ofExample 18 was applied to the laceration and other injuries. The woundwas sutured with horizontal mattress sutures. Phenylbutazone andsystemic antibiotic were given to the filly.

The filly was confined to a stall for 10 days with daily application ofthe cream of Example 18 to the injuries, combined with an oralantibiotic (7 days). The suture was removed at two weeks after severaldays of turn out.

After the 10-day period, the wound healed uneventfully withoutcomplication and the other injuries healed. Hair re-growth also beganquickly.

EXAMPLE 28

A mature Quarter Horse mare presented with a deep wood puncture of theleft buttock and a deep laceration involving the left side of the vulvaextending between the hind legs to the udder. The wounds wereapproximately 6 inches deep with a large vulgar flap.

The mare was sedated, the wound was cleaned and the wood was removed.Phenylbutazone and antibiotic given to the mare. After 4 days, the woundwas trimmed of necrotic, devitilized tissue and the cream of Example 18was applied.

The wound was subsequently cleaned daily and the cream of Example 18applied as the only treatment. No infection or exudate was observed andthe wounds healed at an accelerated rate from the inside out.

After 10 days, the wound was healing nicely with only superficial (lessthan 1 inch depth) wound remaining No lameness or restriction ofmovement was observed, which resulted in a much better than expectedprogress. A full recovery was expected based on this observation.

FIG. 12A depicts the wound before the treatment, FIG. 12B depicts thewound after 10 days of treatment, and FIG. 12C depicts the wound after21 days of treatment with the cream of Example 18.

What is claimed is:
 1. A method for treating acne, melanoma, or basalcell carcinoma in a human or animal in need thereof, comprisingadministering to the human or animal a cream or ointment comprising 10%to 40% (w/w) of tetraethylorthosilicate and an oil, wherein the acne,melanoma, or basal cell carcinoma in the human or animal is effectivelytreated.
 2. The method according to claim 1, wherein thetetraethylorthosilicate is present in a concentration of 20% (w/w). 3.The method according to claim 1, wherein the oil is selected from thegroup consisting of aloe vera oil, chamomile oil, geranium oil, jojobaoil, juniper oil, lavender oil, palm oil, sunflower oil, vanilla oil,almond oil, sweet almond oil, peanut oil, cashew oil, hazelnut oil,macadamia oil, mongongo nut oil, pecan oil, pine nut oil, pistachio oil,walnut oil, avocado oil, cocoa butter oil, coconut oil, corn oil,grapeseed oil, olive oil, sesame oil, rhea butter oil, and soybean oil.4. The method according to claim 1, wherein the cream or ointmentfurther comprises a component selected from the group consisting of anexcipient, stabilizer, moisturizer, thickening agent, emulsifier,emollient, lubricant, surfactant, deodorizing agent, viscositycontrolling agent, solvent, softening agent, alkalizing agent, vitamin,opacifying agent, solubilizer, plant extract, water, chelating agent,humectant, thickener, cryoprotectant, biocide, and nebulizer,anti-oxidant, lipid, peptide, protein, amino acid, anti-aging agent,anti-wrinkle agent, fragrance, essential oil, and preservative.
 5. Themethod according to claim 1, wherein the oil is a combination of cocoabutter, bees wax and sweet almond oil.
 6. The method according to claim1, wherein the tetraethylorthosilicate is present in a concentrationfrom 25% to 40% (w/w).
 7. The method according to claim 1, wherein totaloil content is 10% to 90% by total weight of the cream or ointment. 8.The method according to claim 1, wherein total oil content is 50% to 75%by total weight of the cream or ointment.
 9. The method according toclaim 1, wherein the cream or ointment is administered 1, 2, 3, 4 or 5times daily.
 10. The method according to claim 1, wherein the cream orointment is administered for up to 1 month.
 11. The method according toclaim 1, wherein the cream or ointment is administered for up to 2months.
 12. The method according to claim 1, wherein the cream orointment is not administered with another active agent.
 13. The methodaccording to claim 1, wherein the cream or ointment further comprisesone or more additional components selected from the group consisting ofisopropyl palmitate, lecithin, cl2-15 alkyl benzoate, cetyl alcohol,cetearyl alcohol, ethylhexylglycerin, glycerin usp, glyceryl stearate,hydroxyethyl acrylate/sodium, acryloyldimethyl taurate copolymer, oleicacid, PEG 100 stearate, phenoxyethanol, polymethylsiloxane, purifiedwater, stearic acid, trolamine NF, vitamin E, vitamin E acetate,ethylhexyl stearate, glycerol stearate, PEG 100 stearate,polysorbate-60, aloe, leaf juice, EDTA, sorbitol, cyclomethicone,isothiazolinone, propylene glycol, ceteareth 20, dimethicone,octyldodecanol, phenoxyethanol, and bees wax.
 14. The method accordingto claim 1, wherein when the acne, melanoma or basal cell carcinoma inthe human or animal is treated tissue regeneration occurs.
 15. Themethod according to claim 1, wherein when the melanoma or basal cellcarcinoma in the human or animal is treated a surface lesion resultingfrom the melanoma or basal cell carcinoma is also treated.